Article preview from "The Silver Sheet" - June, 2010
Several FDA warning letters in the last year have cited device firms for alleged violations of Quality System Regulation Sec. 820.72, "Inspection, Measuring and Test Equipment." Below are four examples.
Sample Inspection, Measuring And Test Equipment Citations
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Several FDA warning letters in the last year have cited device firms for alleged violations of Quality System Regulation Sec. 820.72, "Inspection, Measuring and Test Equipment." Below are four examples. |
Syntron Bioresearch (Warning letter date: May 24, 2010) "The Lyophilizer Maintenance and Calibration Procedure ... specified that lyophilizers are to undergo quarterly preventative maintenance by a licensed contractor. However, quarterly preventive maintenance has not been executed for the VirTis and Hull lyophilizers. Additionally, the firm admitted that quarterly maintenance procedures have not been performed by a licensed contractor. A product technician at the firm admitted that the chart recorder used on the VirTis lyophilizer to document lyophilization parameters has not been functioning since mid-December 2009. No service work order had been initiated to repair the broken recorder. The digital caliper ... used in receiving inspection activities is overdue for annual calibration. Last calibration was performed on 10/30/08." Sorin Biomedica (Warning letter date: Oct. 29, 2009) "You have not ensured that the 68 stereoscopic microscopes currently used to perform visual inspection in its receiving inspection and production areas are suitable for their intended purposes, and that the microscopes are capable of producing valid results. [The Calibration/Inspection of Measurement Instruments procedure] does not include microscopes within the list of instruments and equipment. There is no documentation to show that procedures have been established and maintained to ensure the accuracy and fitness for use of the microscopes used for inspection." Phoenix Medical Devices (Warning letter date: Sept. 29, 2009) "There is no calibration record for timers used in production and used during design verification of the Duet and Quartet model stimulators." Marlen Manufacturing & Development (Warning letter date: Aug. 28, 2009) "Your procedures require that a micrometer used to determine material acceptance is to be calibrated twice per year; however, this equipment was last calibrated on 7/21/08." Source: FDA |
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